Has Your DePuy Hip Implant Been Recalled?-FDA Recall List Shown Here

The FDA has recently listed those DePuy ASR Hip Implants subject to the August 2010 recall. Do you have one of those listed below? If so, you should contact your orthropaedic surgeon immediately to set up a follow up appointment.

PRODUCT

1) DePuy ASR 100 Acetabular Implant, 44 mm, 999800744, non-sterile. Recall # Z-2031-2010;

2) DePuy ASR 100 Acetabular Implant, 46 mm, 999800746, non-sterile. Recall # Z-2032-2010;

3) DePuy ASR 100 Acetabular Implant, 48 mm, 999800748, non-sterile. Recall # Z-2033-2010;

4) DePuy ASR 100 Acetabular Implant, 50 mm, 999800750, non-sterile. Recall # Z-2034-2010;

5) DePuy ASR 100 Acetabular Implant, 52 mm, 999800752, non-sterile. Recall # Z-2035-2010;

6) DePuy ASR 100 Acetabular Implant, 54 mm, 999800754, non-sterile. Recall # Z-2036-2010;

7) DePuy ASR 100 Acetabular Implant, 56 mm, 999800756, non-sterile. Recall # Z-2037-2010;

8) DePuy ASR 100 Acetabular Implant, 57 mm, 999890157, non-sterile. Recall # Z-2038-2010;

9) DePuy ASR 100 Acetabular Implant, 58 mm, 999800758, non-sterile. Recall # Z-2039-2010;

10) DePuy ASR 100 Acetabular Implant, 66 mm, 999805966, non-sterile. Recall # Z-2040-2010;

11) DePuy ASR 100 Acetabular Implant, 60 mm, 999800760, non-sterile. Recall # Z-2041-2010;

12) DePuy ASR 100 Acetabular Implant, 62 mm, 999800762, non-sterile. Recall # Z-2042-2010;

13) DePuy ASR 100 Acetabular Implant, 64 mm, 999805764, non-sterile. Recall # Z-2043-2010;

14) DePuy ASR 100 Acetabular Implant, 68 mm, 999806168, non-sterile. Recall # Z-2044-2010;

15) DePuy ASR 100 Acetabular Implant, 70 mm, 999806370, non-sterile. Recall # Z-2045-2010;

16) DePuy ASR 300 Acetabular Implant, 44 mm, 999830744, non-sterile. Recall # Z-2046-2010;

17) DePuy ASR 300 Acetabular Implant, 46 mm, 999830746, non-sterile. Recall # Z-2047-2010;

18) DePuy ASR 300 Acetabular Implant, 48 mm, 999830748, non-sterile. Recall # Z-2048-2010;

19) DePuy ASR 300 Acetabular Implant, 50 mm, 999830750, non-sterile. Recall # Z-2049-2010;

20) DePuy ASR 300 Acetabular Implant, 52 mm, 999830752, non-sterile. Recall #Z-2050-2010;

21) DePuy ASR 300 Acetabular Implant, 54 mm, 999830754, non-sterile. Recall # Z-2051-2010;

22) DePuy ASR 300 Acetabular Implant, 56 mm, 999830756, non-sterile. Recall # Z-2052-2010;

23) DePuy ASR 300 Acetabular Implant, 58 mm, 999830758, non-sterile. Recall # Z-2053-2010;

24) DePuy ASR 300 Acetabular Implant, 60 mm, 999830760, non-sterile. Recall # Z-2054-2010;

25) DePuy ASR 300 Acetabular Implant, 62 mm, 999830762, non-sterile. Recall # 2055-2010;

26) DePuy ASR 300 Acetabular Implant, 64 mm, 999830764, non-sterile. Recall #Z-2056-2010;

27) DePuy ASR 300 Acetabular Implant, 66 mm, 999830766, non-sterile. Recall # Z-2057-2010;

28) DePuy ASR 300 Acetabular Implant, 68 mm, 999830768, non-sterile. Recall # Z-2058-2010;

29) DePuy ASR 300 Acetabular Implant, 70 mm, 999830770, non-sterile. Recall # Z-2059-2010

RECALLING FIRM/MANUFACTURER:

Recalling Firm: Depuy Orthopaedics, Inc., Warsaw, IN, by letter on October 29, 2009

Manufacturer: Depuy International Ltd., Leeds, United Kingdom. Firm initiated recall is ongoing.

REASON:

Notification to clinicians of new revision rate data/information regarding the use of the device. As part of the post-market surveillance, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. As part of the post-market surveillance activities,

the firm recently received and analyzed new data regarding the ASR platform which suggests a higher than expected revision rate for the ASR XL Monoblock Metal-on-Metal (MoM) System linked to usage of monoblock MoM cups with corresponding head sizes below 50mm diameter. As a result of the findings, DePuy Orthopaedics issued a Field Safety Notice to share the new data with the surgeons and reiterate the importance of correct implant positioning and patient selection in achieving optimal implant performance and survivorship. Reasons forrevision are typical for the class of large diameter MoM monoblock cups and includes component loosening, component malalignment, infection, pain, fracture, dislocation and metal sensitivity.

VOLUME OF PRODUCT IN COMMERCE:

36,486 units

DISTRIBUTION

Nationwide

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